MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Break (1069); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Ulcer (2274); Complaint, Ill-Defined (2331)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.(b)(4).

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/pelvic floor.The rep reported that the patient came into the clinic for a normal follow up and was noticed that impedances were out of range.The healthcare professional (hcp) performed a secondary lead check and was able to determine that there was an issue with lead 3.It was noted to be greater than 20,000, meaning there was a break in the circuit.The rep also reported that the patient experienced an increase in symptoms.The rep reported that the patient was scheduled for a revision on (b)(6) 2016.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient reported ever since she was implanted, she has had nothing but issues with her device.She noted that one of her leads had come undone, which was when the pain started sometime in (b)(6) 2016.She was in a lot of pain and finally got a revision surgery scheduled in (b)(6) 2016.The hcp scanned her prior to her revision and told her that her stomach was really bad and had 20 ulcers.She noted that if anything touched her stomach, it would start bleeding.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information received.

Manufacturer Narrative

Product analysis (b)(4):analysis information --(b)(6)2017 12:04:40 cst pli# 10 product id# 37800 below is unedited, system generated text based on the analysis finding code(s) and test results.The implantable neurostimulator (ins) passed functional testing.The ins passed the final functional test on the automated test console.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs.Analysis determined there were no issues when pressing on the ins can.Analysis determined the telemetry was acceptable.Product id 4351-35 serial# (b)(4) implanted: (b)(6)2016: product type lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6181734
• MDR Text Key: 62601638
• Report Number: 3004209178-2016-26645
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/02/2017; 08/02/2017; 08/02/2017
• Supplement Dates FDA Received: 02/24/2017; 06/22/2017; 08/24/2017; 09/28/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR